Infection with either HIV or hepatitis C virus (HCV) affects immune system responses. The purpose of this study is to investigate the immune responses to two different vaccine formulations in HIV-infected, HCV-infected, and HCV/HIV- coinfected individuals.

HCV-infected defined as a positive result using polymerase chain reaction (PCR) without previous HCV-based therapy and without the presence of Child's B or C cirrhosis. These participants will be HIV-uninfected.

Biological: Twinrix

Combined hepatitis A and hepatitis B immunization

Biological: Decavac

Diphtheria and tetanus toxoid vaccine

Experimental: B

HIV-infected and ARV naive, with a CD4 cell count of 300 cells/mm3 or greater, with no prior or current opportunistic infection, and with no indication for HIV therapy. These participants will be HCV-uninfected.

Biological: Twinrix

Combined hepatitis A and hepatitis B immunization

Biological: Decavac

Diphtheria and tetanus toxoid vaccine

Experimental: C

HCV/HIV-coinfected as defined above in Arms A and B.

Biological: Twinrix

Combined hepatitis A and hepatitis B immunization

Biological: Decavac

Diphtheria and tetanus toxoid vaccine

Detailed Description:

Individuals with HCV and HIV coinfection are especially hard to treat, and as a result, account for a high rate of deaths each year. Because HCV and HIV share transmission routes, HCV/HIV coinfection is common. Liver disease has emerged as a significant cause of death in individuals coinfected with HCV and HIV. Currently, the mechanisms by which HCV and HIV interact in HCV/HIV-coinfected individuals, including how these infections affect immune responses, are poorly understood. Research suggests that vaccination may prevent other comorbidities associated with HCV/HIV coinfection; however, responses to new vaccine antigens have been shown to be impaired in HCV or HIV-infected individuals. The purpose of this study is to identify the innate and adaptive immune defects present in HCV-infected, HIV-infected, and HCV/HIV-coinfected individuals. This study will evaluate whether these innate and adaptive immune defects predict responses to HBV neoantigen in the form of both a diphtheria/tetanus toxoid immunization (Decavac)and a hepatitis A-hepatitis B immunization (Twinrix).

This study will last approximately 24 weeks. Participants will be stratified to one of three arms, based on their HCV and HIV status:

Arm A will enroll HCV-infected individuals who are HIV-uninfected

Arm B will enroll HIV-infected individuals who are HCV-uninfected

Arm C will enroll HCV/HIV-coinfected individuals

Arms B and C will open for enrollment before Arm A. Opening of enrollment for Arm A will be determined by the accrual progress of Arms B and C as evaluated by the ACTG Scientific Agenda Steering committee.

All participants will receive Decavac vaccination on Day 0, and a Twinrix vaccination on Days 0, 7, and 21. Study visits will occur around Days 0, 7, and 21, and at Weeks 6, 8, 12, and 24; all visits will include medical and medication history, blood collection, and a physical exam. Medication to treat HCV or HIV will not be provided by the study.

Eligibility

Ages Eligible for Study:

18 Years to 65 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria for Arm A Participants:

HCV-infected

HIV-uninfected

Inclusion Criteria for Arm B Participants:

HIV-infected

HCV-uninfected

CD4 count greater than or equal to 300 cells/mm3 within 60 days prior to study entry

Serious illness requiring systemic treatment and/or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.

Current uncontrolled seizure disorders

Active bleeding varices, or Child's B or C cirrhosis. More information on this criterion can be found in the protocol.

Serious bleeding disorder that poses a risk to a participant for intramuscular injections

Known allergy or sensitivity to study vaccines or their formulations

Current drug or alcohol use that, in the opinion of the investigator, interferes with study participation

Pregnant or breastfeeding

Use of systemic investigational agents within 30 days prior to entry

History of any hepatitis A vaccine within one year

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393276